Quality & Regulatory

Practice drives everything we do

In our industry, Quality & Regulatory (Q&R) holding the highest standards - helping us to create better, safer, and more affordable medicines that benefit people today and generations to come.

cGMP compliance with International Convention on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q7 ‘Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)’ standards aligned with the concepts established by the International Organisation for Standardization (ISO) (ISO 9000 standards).

Meeting EU regulationsWe are also registered with the European Union (EU) Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) from 1 June 2007; as well as the latest Biocidal Products Regulation (EU BPR 528/2012).

Alongside additional market challenges such as globalization, burgeoning population growth, and global economic pressures, require ingredient manufacturers to commit to even higher levels of responsibility, integrate Q&R issues even earlier in processes and R&D developments.

Certificate of Suitability: What makes us unique?

We are currently the only supplier of calcium lactate with a Certificate of Suitability (CEP) – granted by the European Directorate for the Quality of Medicines in Strasbourg. What’s more, calcium lactate can be registered as an Active Pharmaceutical Ingredient as well as an excipient.